Angion Biomedica and Vifor Pharma announced that their Phase III trial on ANG-3777 for renal transplant patients did not meet the study’s primary and secondary endpoints.

Novavax

Novavax Inc. said on Oct. 27 the company had completed the real-time submission of an application for the authorization of the Covid-19 vaccine candidate NVX-CoV2373 in the United Kingdom.

The U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee recommended emergency use authorization (EUA) for the Pfizer-BioNTech vaccine for children 5 through 11 years of age, with 17 members voting yes and one abstention.

A booster dose of the Covid-19 vaccine developed by Pfizer Inc. and German partner BioNTech SE restored efficacy to 95.6 percent against the virus, including the Delta variant, data released by the companies from a large study showed on Oct. 21.

SOLVE(D), IPG Health

SOLVE(D), IPG Health’s data, analytics and media company, announced the addition of five industry leaders to the agency, boosting the unit’s leadership bench strength.

Biogen Inc. is pinning hopes on a decision on U.S. government coverage of the company’s Alzheimer’s disease drug during 2022 to help drive up Aduhelm’s usage, after a big miss on third-quarter 2021 sales of the much-awaited treatment.

A late-stage trial of Biogen Inc.’s experimental treatment for an inherited form of amyotrophic lateral sclerosis (ALS) failed to reach the study’s main goal, but secondary measures and biomarkers showed favorable trends, the company said on Oct. 17.

Outside advisers to the U.S. Food and Drug Administration on Oct. 15 unanimously recommended the regulatory agency authorize a second shot of Johnson & Johnson’s Covid-19 vaccine for all recipients of the one-dose inoculation.

The U.S. Food and Drug Administration on Oct. 12 allowed British American Tobacco Plc to market the company’s Vuse Solo e-cigarettes and tobacco-flavored pods, the first-ever vapor product to get clearance from the health regulator.

People who received Johnson & Johnson’s Covid-19 vaccine will have a stronger neutralizing antibody response if they get an mRNA shot as the second dose, Axios reported on Oct. 12, citing a person who has seen data collected by the U.S. National Institutes of Health (NIH).